The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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20301–20325 of 27682

  • HighFDA (Devices)·Z-1062-2017·2017-02-01

    Philips Velara Generator Recall for System Lockup Risk

    Philips is recalling 59 Velara Generators with old firmware used with the Integris BH5000 because the system may lock up.

    Product
    Velara Generator with an old Firmware version used with the Philips Integris BH5000
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1091-2017·2017-02-01

    Merge Hemo software recall due to potential connection issues

    Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the Hemo Monitor may fail to communicate with the Client PC during power-up.

    Product
    Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2017·2017-02-01

    Hitachi Oasis MRI C-Spine Coil Recalled Due to Overheating Balun

    Hitachi Medical Systems America Inc is recalling 180 Hitachi Oasis MRI System C-Spine Coils because the coil balun was found to be hot to the touch after an exam.

    Product
    Hitachi Oasis MRI System - C-Spine Coil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2017·2017-02-01

    Baxter Recalls Phoenix Dialysis Machine Preventive Maintenance Kits

    Baxter Healthcare is recalling Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone connectors that may cause fluid leaks during dialysis.

    Product
    Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1090-2017·2017-02-01

    Roche Recalls Five cobas p 612 Pre-analytical Systems in Texas and Washington

    Roche Diagnostics is voluntarily recalling five cobas p 612 pre-analytical systems in Texas and Washington. The recall was initiated on December 27, 2016, and classified as Class II.

    Product
    cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1092-2017·2017-02-01

    Roche Tina-Quant CRP Latex Test System Recalled for Low Results

    Roche is recalling Tina-Quant CRP Latex High Sensitive test kits due to potential under-recovery of results, which may lead to incorrect cardiovascular risk assessments.

    Product
    Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0970-2017·2017-01-25

    Bard Halo One Introducer Sheath Recalled for Separation and Kinking

    Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to complaints of sheath separation, kinking, and tip damage during use.

    Product
    Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1044-2017·2017-01-25

    Elekta Monaco RTP System Recalled for Incorrect Dose Calculation Errors

    Elekta, Inc. is recalling the Monaco RTP System because editing beam numbers and wedge angles can result in incorrect dose calculations for radiation therapy patients.

    Product
    Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    27 states
  • SevereFDA (Devices)·Z-0977-2017·2017-01-25

    BioMerieux NucliSENS magnetic extraction reagents recalled for performance drift

    BioMerieux SA is recalling NucliSENS magnetic extraction reagents because a performance drift was observed in BK virus testing for certain silica batches.

    Product
    NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids from biological specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1026-2017·2017-01-25

    Fresenius 2008T Hemodialysis System Recalled for Software Error

    Fresenius Medical Care is recalling 2008T Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled ultrafiltration rate instead of the displayed rate.

    Product
    Fresenius 2008T Series Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0950-2017·2017-01-25

    CareFusion Recalls Alaris Pump Modules Due to False Air-in-Line Alarms

    CareFusion is recalling Alaris Pump Modules and AIL sensor kits because false Air-in-Line alarms can interrupt medication infusions.

    Product
    Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0969-2017·2017-01-25

    Bard Halo One Introducer Sheath Recalled for Separation and Kinking

    Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to reports of sheath separation, kinking, and tip damage during use.

    Product
    Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0968-2017·2017-01-25

    Bard Halo One Introducer Sheath Recalled for Separation and Kinking

    Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to complaints of separation, kinking, and tip damage during use.

    Product
    Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1027-2017·2017-01-25

    Fresenius 2008K Hemodialysis System Recalled for Software Error

    Fresenius Medical Care is recalling 2008K Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled Ultrafiltration Rate setting.

    Product
    Fresenius 2008K Series : Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0976-2017·2017-01-25

    BioMerieux Recalls MagSIL Magnetic Silica Reagents Due to Performance Drift

    BioMerieux SA is recalling 3,723 units of MagSIL (NucliSENS easyMAG Magnetic Silica) worldwide due to observed performance drift in BK virus testing.

    Product
    MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1029-2017·2017-01-25

    Fresenius 2008K@home Hemodialysis System Recalled for Software Defect

    Fresenius Medical Care is recalling 2008K@home hemodialysis systems because a software error may cause the machine to execute a cancelled ultrafiltration rate.

    Product
    Fresenius 2008K@home Series : Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2017·2017-01-25

    Binding Site Optilite Analyser Recalled for Lid Injury Risk

    The Binding Site Group is recalling 129 Optilite Analyser units because the lid may fall suddenly and cause injury if not fully open.

    Product
    Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1053-2017·2017-01-25

    Freelite Human Lambda Free Kit Recalled for Calibration Curve Error

    The Binding Site Group is recalling Freelite Human Lambda Free Kits due to a calibration curve change that causes an increase in false prozone flags.

    Product
    Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2017·2017-01-25

    Merge Cardio software recalled for potential image loading errors

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because a specific user action may cause images to be missing, potentially leading to incorrect diagnosis or treatment.

    Product
    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1051-2017·2017-01-25

    Great Basin Staph ID/R Blood Culture Panel Recalled for False Positives

    Great Basin Scientific is recalling the Staph ID/R Blood Culture Panel because the S. aureus probe could result in false positive results.

    Product
    Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2017·2017-01-25

    Baxter Peritoneal Dialysis Set Recalled for Reported Leaks

    Baxter Healthcare is recalling 8,640 APD Set with Cassette 3-Prong Peritoneal Dialysis Sets due to customer complaints about leaks.

    Product
    APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1033-2017·2017-01-25

    Meridian Premier EHEC Diagnostic Kits Recalled for False Positive Results

    Meridian Bioscience is recalling Premier EHEC and Premier EHEC Bulk diagnostic kits because internal testing showed they can produce false positive results with some broth specimens.

    Product
    PREMIER EHEC and PREMIER EHEC Bulk.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-1034-2017·2017-01-25

    Ultradent NanoTips 30g Dental Tips Recalled for Loose Cannula

    Ultradent Products, Inc. is recalling NanoTips 30g dental tips because the stainless steel cannula may detach from the base, posing a risk during intra-oral procedures.

    Product
    NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2017·2017-01-25

    Fresenius 2008K2 Hemodialysis System Recalled for Software Error

    Fresenius Medical Care is recalling 2008K2 hemodialysis systems because a software error may cause the machine to execute a cancelled ultrafiltration rate instead of the displayed rate.

    Product
    Fresenius 2008K2 Series : Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide